Wound irrigation and debriding system

ABSTRACT

A method and device for use as a non-invasive pre-filled, self contained, single use, disposable, sterile wound irrigation and debriding system, comprising a pre-filled unit of USP saline solution or sterile water, preferably 120-200 cc. The unit is a flexible, free standing, chamber containing the saline solution and affixed to a nozzle, which may be straight or angled, having a delivery tip and optional return air filter. The device of the present invention is provided in two embodiments, the first being one in which the nozzle is screwed onto the chamber, and the second being a single molded unit. In both configurations, the device is pre-filled, fully assembled, sterilized and packaged at point of manufacturing and delivered in a no-assembly required, ready to use state. The material need for the device is flexible, preferably plastic.

This application is a continuation-in-part of co-pending application Ser. No. 09/364,343.

FIELD OF THE INVENTION

This invention relates to medical apparatus and method for the irrigation and debriding of wounds and incisions and more particularly to a device and method in which a unit dose of sterile (USP) saline solution or a sterile water solution is dispensed for the cleansing of a wound or incision.

Unlike invasive medical procedures such as enemas or blood transfusions, for example, wound irrigation and debriding techniques (i.e., cleaning a wound or incision by irrigation and/or debriding and removal of potentially infecting germs and particles) are inherently non-invasive.

“Irrigation” is the application of a gentle lavage to cleanse the wound/incision. Depending on the nature of the wound/incision, as in the case of removing dead tissue or exudate, it may be necessary to deliver the solution with much more force (approximately 8 psi). This is called “debriding”

BACKGROUND OF THE INVENTION

The accepted, long standing, current method of wound irrigation/debriding delivery systems is comprised of the following independently packaged items: a sealed sterilized bottle of saline solution or sterile water, a sterile (e.g. 16 oz.) bowl, and a sterile syringe. The accepted procedure involves opening all items, placing them onto a sterile field, unsealing the bottle of saline solution or sterile water, pouring it into the now-opened bowl and then drawing it up into the syringe. The system is now ready to irrigate or debride the wound or incision. The two major drawbacks to the current system are as follows. The first drawback is the precious time that is lost, especially in an emergency, to unpack and assemble this system for use. The second, and most critical drawback, is the immediate exposure of all of these items to local contaminates. Once the seal on the bottle of saline solution is broken, the solution is now subject to contamination. This is even more so when the solution is poured into the now-exposed bowl. The already exposed solution is then drawn into the sterile syringe. The entire wound irrigation system is thus potentially contaminated. The sterile field on which this operation is performed is a sterilized, prepackaged sheet of paper that is removed from its protective packaging, unfolded and placed upon whatever surface the attending person is using for the procedure. If this surface becomes wet, it is then considered contaminated and rendered ineffective. The surface could be in a hospital operating or emergency room, a school nurse's office, an accident site, or a military field hospital. All are areas that could easily contaminate the exposed, current wound irrigation/debriding systems. An example of this contamination could be Staph Infection, which is easily spread, especially in hospital environments.

This infection, which is technically Methacillan Resistive Staph Aurious (MRSA), is extremely difficult to treat, requiring prolonged hospital stays and intravenous antibiotics. In addition to MRSA, there are many other airborne pathogens which can contaminate the irrigation solution in the open bowl used in the presently available wound irrigation/debriding systems.

Although the current medical procedure has been in continuous use for quite some time, it would nevertheless, be extremely efficacious and safer, if a suitable wound irrigation/debriding device and method could be provided which would avoid possible contamination of the solution.

It is, therefore, an object of the present invention to provide a quick, efficient and much safer wound irrigation and debriding delivery system.

Another object of this invention is to provide a non-invasive one-piece system, which can be pre-sterilized and easily stored in a ready-to-use condition to provide quick, safe and effective treatment when needed.

It is yet another object of this invention to provide a quick, easy-to-use, self-contained device which saves substantial time and expense.

It is yet another object of this invention to eliminate the Sharps Biohazard Waste associated with the prior art wound irrigation/debriding systems. These current systems employ the use of a needless syringe. This syringe, like all syringes, whether invasive or non-invasive, must, by law, be discarded into a Sharps Hazard Container, at considerable cost to the facility. The present invention eliminates all Sharps Hazard requirements in the wound irrigation and debriding process.

SUMMARY OF THE INVENTION

An improved non-invasive medical procedure and apparatus has been discovered for the irrigation/debriding of wounds and incisions which is not prone to the contamination dangers of prior-art systems. The invention consists of the irrigation/debriding solution, a solution chamber, a non-invasive nozzle, a nozzle protective tip with a removable packaging band around it for additional protection during storage and moving, and an optional filter. In one embodiment, the nozzle assembly is screwed onto the solution chamber at point of manufacture. In another embodiment, the nozzle and solution chamber are molded into one unit during the manufacturing process. The entire device is made of a flexible material, preferably plastic. All separate items, of each embodiment, are assembled into one unit, sterilized, and packaged at the point of manufacture and shipped ready to use. Preferred quantities and type of solution are 120-200 cc of USP saline solution or of sterile water. Since the nozzle is non-invasive, there is no reason for lubricating it, and the nozzle can be comparatively much longer than an invasive device (e.g., an enema).

BRIEF DESCRIPTION OF THE DRAWINGS

These and other objects of the present invention and the various features and details of the operation and construction thereof are hereinafter more fully set forth with reference to the accompanying drawings, where:

FIG. 1 is a perspective view of the complete assembly where the nozzle may be screwed on or molded to the chamber;

FIG. 2 is a perspective view of the solution chamber adapted for a screw-on nozzle.

FIG. 3 is a perspective view of a screw-on nozzle.

FIG. 4 is a perspective view of two optional filters.

FIG. 5 is a perspective view of a molded assembly.

DETAILED DESCRIPTION OF THE INVENTION

The preferred embodiment of the invention, as shown in FIG. 1 comprises, a chamber 10, constructed of a flexible, semi-ridged material, preferably plastic, having a flat base 10 a at one end and, at the other end 10, having an outlet 10 c, and containing sterile irrigation/debriding solution 11; and a delivery nozzle 14 having two open ends, one end of which (14 a) is affixed to outlet 10 c and the other end of which (14 b) has an opening to dispense the sterile solution and a protective tip 13 around which is wrapped packaging band 12. The protective tip 13 and packaging band 12 maintain the security of the system during shipment and in storage prior to use.

Solution 11 is 0.9% USP Sodium Chloride or it may be processed sterile water, ensuring its compatibility with the body; i.e., solution 11 does not change the osmotic characteristics of the human body's organs, nor the organs of animals.

Delivery nozzle 14 may be straight or angled relative to outlet 10 c of chamber 10. In the preferred embodiment of FIG. 1, nozzle 14 (at end 14 a) is at an angle of thirty degrees (30°) relative to output 10 c. However, the angle may be anywhere between zero degrees (0°) and forty five degrees (45°), upwards or downwards, depending upon the preferred point of access to the incision or wound. Nozzle 14 may be configured (as shown in FIGS. 2 and 3) to screw onto solution chamber 10 or it may be molded as one piece to solution chamber 10 (FIG. 5). Both configurations are assembled at point of manufacture into a single-piece, disposable, sterile unit.

As shown in FIG. 1, the dispensing end 14 b of nozzle 14 is curved at a fifteen degree (15°) angle from chamber end 10 b. The preferred angle of curve may be from ten degrees (10°) to thirty degrees (30°), depending on the location of the wound/incision. Other tapering angles may be chosen as needed. Nozzle 14 may be round or oval in shape.

In the preferred embodiment, solution chamber 10 is tapered for fuller and more efficient evacuation of the solution, although the invention need not be limited to a tapered chamber. In the preferred embodiment, solution chamber 10 is five inches (5″) in height at base 10 a and tapering to three and two-tenths inches (3.2″) approximately at end 10 b. Nozzle 14 measures anywhere from two and three-quarters inches (2¾) to approximately four inches (4″) long, whether molded to the chamber or screwed on. In this configuration chamber 10 has a capacity of 120 cc of solution. These measurements may vary, however, depending on usage.

When it is necessary to use the assembly, it is taken from its place of storage into the general area of use as, for example, a hospital emergency room, outpatient clinic, operating room, nursing station, patient room, physician's office, field hospital, or other medical/veterinarian application.

The device of the present invention is free standing and can be conveniently placed on base 10 a anywhere in the sterile field being used for this procedure. When ready for use, packaging band 12 is removed. The protective tip 13 is then removed from the nozzle and the irrigation/debriding process is effected by applying hand pressure to the walls of solution chamber 10. The sterile irrigation solution (a sterile water or a USP saline solution) passes from chamber 10, through outlet 10 c into nozzle 14 to the wound/incision area. Solution chamber 10 is made of a flexible material, such as plastic, but it is semi-ridged because it is designed to administer solution 11 over several applications while keeping solution 11 in a sterile state (as opposed, for example, to an invasive device, such as an enema, which is designed to deliver one, quick dose).

When solution flow is stopped, the air reentering chamber 10 may be further protected from contamination by employing an optional filter 15, located between outlet 10 c of chamber 10 and nozzle end 14 a, as shown in FIGS. 1 and 5. Two such filters are shown in FIG. 4, a Mitral filter valve 15 a and a Clapper filter 15 b.

Mitral filter valve 15 a is a diaphragm of filter medium that expands under internal pressure to create an orifice and collapses back into place with the release of internal pressure. Another embodiment is a Clapper Filter 15 b, which is filter medium assembled to a one-directional clapper valve frame. Both filter types operate on the same basis. When pressure is applied from inside, filter 15 opens to allow passage of fluid from chamber 10 through its outlet 10 c, through delivery nozzle 14 to the wound or incision. When pressure is released, the returning air to chamber 10 returns filter 15 to its original position, thereby allowing the filtration of the returning air to chamber 10. This filtration minimizes the contamination of the remaining irrigation/debriding solution during necessary interruptions in the irrigation/debriding treatment.

Since the entire assembly can be placed in an upright, free standing position on base 10 a with protective tip 13 reinserted, nozzle 14 is prevented from possible contact with contaminated areas, allowing for safer interruptions of the wound care procedure. When solution 11 is depleted, the empty device may be discarded in its entirety, in any common waste receptacle. No Sharps Hazard Disposal requirements apply to the device of the present invention, since it does not employ a syringe. 

1. A one piece, non-invasive, sterile dispenser for the irrigation/debriding of wounds and incisions in a human or animal body, which is disposable in any container, comprising: a flexible chamber having an internal volume containing a sterile solution of a composition compatible with and the osmotic characteristics of the body's organs, said chamber having two ends, the first end being closed, and having a flat base, and the second end having an outlet orifice; a nozzle having a first end and a second end, both of said ends being open, said first end being affixed to said orifice of said chamber. a removable protective tip affixed to said second end of said nozzle, thereby maintaining said solution in a sterile state prior to and after use; and a removable packaging band around said protective tip for transport and storage; wherein, when said protective tip and said packaging band are removed and pressure is applied to said chamber, said solution is dispensed from said first end through the opening of said second end into the wound being irrigated and debrided.
 2. The dispenser of claim 1 wherein said nozzle contains a filter at said first end.
 3. The dispenser of claim 1 wherein said nozzle has a screw-on cap affixing said first end to said orifice of said chamber.
 4. The dispenser of claim 1 wherein said nozzle is molded to said chamber.
 5. The dispenser of claim 1 wherein said sterile solution contains 0.9 percent USP sodium chloride.
 6. The dispenser of claim 1 wherein said sterile solution contains sterile water.
 7. The dispenser of claim 1 wherein said chamber is tapered.
 8. The dispenser of claim 1 wherein the first end of said nozzle is affixed to said orifice of said chamber at an angle between zero degrees (0°) and forty five degrees (45°).
 9. The dispenser of claim 1 wherein said nozzle is curved towards said second end such that said second end of said nozzle is at an angle from 10 degrees (10°) to thirty degrees (30°) relative to said second end of said chamber.
 10. A method for the irrigation and debriding of wounds in the human or animal body, utilizing a non-invasive, one-piece sterile unit consisting of a flexible tapered chamber having an internal volume containing a sterile solution of a composition compatible with the osmotic characteristics of the body's organs, said chamber having two ends, one end being closed and having a flat base, and the other end having an outlet orifice at one end thereof and being tapered towards said outlet orifice; a nozzle having a first end and a second end, both of said ends being open, said first end having an optional filter, and being affixed to said orifice of said chamber by a screw-on cap or by being molded thereto. said nozzle being affixed to said orifice of said chamber at an angle between zero degrees (0°) and forty-five degrees (45°) and being curved toward the tip of said second end such that said second end is at an angle of from 10 degrees to 30 degrees relative to said first end; a removable protective tip cover affixed to said second end of said nozzle, thereby maintaining said solution in a sterile state prior to and after use; and a removable packaging band around said protective tip cover for transport and storage; said method comprising the following steps: First, retrieve a packaged sterile pad and said one-piece sterile unit; Second, remove said sterile pad from its packaging, open it, and place said pad in the working area; Third, remove the packaging and protective tip cover from said one-piece sterile unit and place said unit in an upright position; Fourth, hold said one-piece sterile unit, point said tip of said unit at the area of the wound to be irrigated, and squeeze said flexible chamber of said unit thereby dispensing said sterile solution through the second end of said unit into the wound; Fifth, repeat step four as often as needed; Sixth, after finally completing the irrigation/debriding process, discard said sterile pad and said one-piece sterile unit into any wastebasket, after use. 